Plain English Summary

Background and study aimsA hip fracture is where there is a break in the upper thigh bone (femur). They are very common affecting around 60,000 people each year, particularly in older adults. A hip fracture is a potentially catastrophic event, with approximately 30% of patients dying within a year of the injury and the rest experiencing a significant reduction in their quality of life. The most common type of hip fracture is treated with a partial hip replacement or hemi-arthroplasty. The hemi-arthroplasty can be fixed to the patient’s thigh bone with or without the use of ‘bone cement’. Cement is the current standard technique, but there are some risks with bone cement which could be avoided by using ‘uncemented’ implants. These risks, which include an increased risk of death during the first 24 hours after surgery, have prompted a recent alert from the National Patient Safety Agency. Traditionally, early types of uncemented implants led to worse outcomes for patients compared to cemented implants. Now however, there have been significant improvements in uncemented implant technology and the current, limited evidence suggests that these modern implants may be as good as the cemented implants but without the risks of using cement. The aim of this study is test whether there are differences in patients’ quality of life following treatment with one of these hemiarthroplasty implants. The study will also test whether one treatment is more cost-effective than the other, and whether either treatment impacts on blood pressure.

Who can participate?Patients aged 60 and older who have fractured their hip and will receive treatment with a hemiarthroplasty

What does the study involve?Participants are randomly allocated to one of two groups. Those in the first group undergo surgery to fix their hip fracture using traditional cemented implants. Those in the second group undergo surgery to fix their hip fracture using modern uncemented hemiarthroplasty implants. Following fixation of their hip fracture, all patients undergo a routine rehabilitation before they are discharged from hospital. Patients or their carers are asked to complete a questionnaire to assess their quality of life at the start of the study, and then 4 weeks, 4 months and 12 months later. In addition some routinely collected data is sent to the study team, including notes about the operation, discharge details, and blood pressure measurements taken during surgery. After completing the 12-month questionnaire, patients have completed their participation in the study and continue to be treated as per normal standard of care.

What are the possible benefits and risks of participating?There is no specific advantage to taking part in the study. However, the information from this trial will help provide information about which treatment is best for patients with this type of injury. Any operation for a broken hip carries some risks. The risks of surgery with both implants include: bleeding, infection, further fracture, dislocation, leg length discrepancy, blood clots, damage to nerves and blood vessels, and the risks associated with the anaesthetic. These risks are the same as for patients who are not part of this research project. There are also uncommon risks associated with each type of hip replacement. In a small number of cases, patients having a cemented replacement can have a reaction to the bone cement, and in a small number of uncemented replacements there may be an extension of the fracture during surgery. If either event were to occur, the anaesthetist and surgeon would continue treatment as per normal practice.

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Study information

Scientific title

A randomised controlled trial to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures

Acronym

WHiTE Five

Study hypothesis

Feasibility study:The aim of this study is to establish the feasibility of conducting a full-scale trial comparing cemented with modern uncemented hemiarthroplasty implants.

Main phase of the study (added 11/04/2018):The aim of this randomised controlled trial is to compare the health-related quality of life in participants over 60 years of age with a displaced intracapsular hip fracture receiving contemporary uncemented hemiarthroplasty versus the current standard-of-care cemented hemiarthroplasty.

Study design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

See additional files

Condition

Hip fracture

Intervention

Patients will be randomly assigned a treatment using a web-based randomisation system, this will make sure that about the same number of patients in each participating hospital are assigned each treatment. Patients will then undergo surgery at the next available opportunity on a planned trauma list. The exact surgical procedures will be as per local guidelines. Following surgery patients will undergo a routine rehabilitation programme as per local guidelines.

Cemented hemiarthroplasty: the neck and head of the femur will be replaced with a cemented femoral stem. This is the current standard of care in many UK hospitals

Uncemented hemiarthroplasty: the neck and head of the femur will be replaced with a modern (contemporary) uncemented femoral stem. Uncemented stems are already used as standard practice in some UK hospitals.

Feasibility study:Participants will be asked to complete a questionnaire during their initial stay in hospital, 1 month after their operation, and 4 months after their operation. This will usually be done in-person or over the telephone, and may be sent by post. If the patient is unable to answer the questions then an appropriate consultee will be asked to answer on the patient’s behalf. The short questionnaire is about quality of life before and after the injury, and the amount of care the patient receives.

Main phase of the study (added 11/04/2018):Participants will be asked to complete a questionnaire during their initial stay in hospital, and 1, 4 and 12 months after their operation. This will usually be done in-person or over the telephone, and may be sent by post. If the patient is unable to answer the questions then an appropriate consultee will be asked to answer on the patient’s behalf. The short questionnaire is about quality of life before and after the injury, and the amount of care the patient receives.Some hospitals will contribute intraoperative and post-operative haemodynamic measurements for enrolled patients. These will be used to determine the feasibility of collecting this data on a larger scale, and to assess any observed difference in haemodynamic parameters between groups.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Feasibility study:Recruitment rate, calculated from the number of patients screened and recruited at each participating hospital. Logs of screened and recruited patients monitored monthly.

Main phase of the study (added 11/04/2018):Quality of life, measured using the EQ-5D-5L score at 4 months post-randomisation

Secondary outcome measures

Feasibility study:1. Quality of life, measured using the EQ-5D-5L questionnaire at baseline (retrospective/pre-injury), 1 month and 4 months after surgery2. Trial feasibility, assessed by analysing the reasons given by potential patients who chose not to participate (or who later withdraw), monitored continuously throughout the trial3. Changes in blood pressure during and immediately after surgery, calculated from routinely collected blood pressure measurements

Intention to publish date

Participant level data

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

15/01/2020: The total final enrolment number has been changed from 1228 to 1225.
10/12/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/11/2019 to 04/12/2019.
2. The overall end date was changed from 31/10/2020 to 31/12/2020.
3. The intention to publish date was changed from 01/03/2021 to 01/05/2021.
4. The total final enrolment was added.
5. The plain English summary was updated to reflect these changes.
05/08/2019: The new participant information sheet has been uploaded.
02/08/2019: The following changes were made to the trial record:
1. Trial participating centres added.
2. The recruitment end date was changed from 30/09/2019 to 01/11/2019.
3. The intention to publish date was changed from 28/02/2019 to 01/03/2021.
4. Contact details updated.
26/03/2019: The condition has been changed from "Specialty: Injuries and emergencies, Primary sub-specialty: Musculoskeletal Trauma; UKCRC code/ Disease: Injuries and Accidents/ Injuries to the hip and thigh" to "Hip fracture" following a request from the NIHR.
11/04/2018: The following changes were made to the trial record:
1. The scientific title was changed from 'World hip trauma evaluation five: a feasibility study comparing cemented and uncemented implants for the treatment of hip fractures' to 'World hip trauma evaluation five: a randomised controlled trial comparing cemented and uncemented implants for the treatment of displaced intracapsular hip fractures'.
2. The public title was changed from 'A feasibility study to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures' to 'A randomised controlled trial to compare contemporary un-cemented hemiarthroplasty with the standard-of-care cemented hemiarthroplasty for the treatment of displaced intracapsular hip fractures'.
3. John Radcliffe Hospital, King’s Mill Hospital, Sandwell General Hospital, Wexham Park Hospital, and Blackpool Victoria Hospital were added to the trial participating centres.
4. The hypothesis, ethics approval, interventions, primary and secondary outcome measures and inclusion criteria were updated.
5. The recruitment end date was changed from 31/08/2017 to 30/09/2019.
6. The overall trial end date was changed from 28/02/2018 to 31/10/2020.
7. The target number of participants was changed from 100 to 1128.
09/11/2017: The ISRCTN prospective/retrospective flag compares the date of registration with the recruitment start date and does not include any grace period. The registration of this study was requested through the NIHR Portfolio and was finalised within 6 months of the recruitment starting.